NCT06011382

Maxillary Molar Distalization Supported by Mini-implants With the Advanced Molar Distalization Appliance (Amda®)

Maxillary Molar Distalization Supported by Mini-implants With the Advanced Molar Distalization Appliance (Amda®): A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Grigore T. Popa University of Medicine and Pharmacy · Academic / Other
• Sex: All
• Age: 14 Years – 20 Years
• Healthy volunteers: Accepted

Summary

The aim of this randomized controlled clinical trial is to evaluate the dentoalveolar and skeletal treatment effects of the AMDA when used for distalization of the maxillary first molars in patients with Class II malocclusion in the permanent dentition.

Detailed description

The primary aim is to evaluate two different treatment groups from initiation of treatment up until completion of maxillary molar distalization of: * Group I: patients treated with amda® * Group II: patients treated with buccal mini-implants More specifically to evaluate the efficiency of the AMDA using lateral cephalograms and digital 3D model casts of the patients under investigation at the following time points: * point T0: baseline data - before initiation of the treatment * point T1: immediately after distalization (8-12 months)

Conditions

• Angle Class II

Interventions

Type	Name	Description
DEVICE	Advanced Molar Distalization Appliance (amda®)	AMDA is a prefabricated device anchored to the palate by miniscrews and it is a noncompliance appliance for maxillary molar distalization
DEVICE	Buccal mini-implants	Buccal mini-implants for maxillary molar distalization

Timeline

• Start date: 2022-06-20
• Primary completion: 2024-06-20
• Completion: 2025-06-20
• First posted: 2023-08-25
• Last updated: 2023-08-25

Locations

1 site across 1 country: Romania